Digestion of food begins in the mouth, continues in the stomach and is completed in the small intestine. Saliva contains an enzyme called ptyalin, an a-amylase, which begins the process of digestion by breaking down carbohydrates. Ptyalin remains active in the stomach and continues its digestion of carbohydrates until acid is produced in the stomach and gastric pH decreases. Along with acid, the stomach also produces an enzyme known as pepsin. Pepsin is a protease, which digests proteins. Pepsin is only active at the low pH of the stomach. The partially digested mixture then moves into the small intestine where the acid is neutralized by bicarbonate and the pH elevates to neutral. The various proteases, carbohydrases and lipases produced by the pancreas and the cells of the small intestine then further break down the partially digested food into a form that can be absorbed by the body. This is the ideal digestive process. However, most people occasionally suffer from some kind of digestive disorder. The most commonly occurring digestive problems are heartburn, indigestion and flatulence.
Heartburn and other maladies caused by the acid in the stomach can be a mild annoyance, or they can be a sign of a pathological disorder, such as gastroesophageal reflux disease (GERD). Gastroesophageal reflux occurs when the stomach contents, particularly the acid, move up into the esophagus, and is usually caused by a weakened lower esophageal sphincter. Though this condition can be caused by an abnormality in the esophageal sphincter, frequently it results from external factors. Certain foods can cause the sphincter to relax, and obesity puts excess pressure on the sphincter, which can cause or worsen the condition. The lining of the esophagus is not equipped to resist the corrosion caused by the acid and slowly erodes. If left untreated this erosion can lead to esophageal cancer.
However, digestive problems can result from many other factors as well. The consumption of too many fatty foods, physical and emotional stress, smoking, alcohol, other health conditions, exposure to pollution and pathogens, amount of exercise, and the amount and type of food consumed can all contribute to digestive disturbances. Any situation that impedes the secretion of stomach acid and bicarbonate, or the release of the proper digestive enzymes can negatively impact digestion.
There are numerous medications available that can effectively treat heartburn and indigestion. Medications useful in treating heartburn are antacids and H2 blockers. Antacids, which are mostly calcium carbonate, magnesium hydroxide, aluminum hydroxide, and/or sodium bicarbonate tablets, work by neutralizing the acid produced in the stomach. On the other hand, H2 blockers are drugs that inhibit the production of acid in the stomach. Both types of medication are effective in treating heartburn and usually eliminate symptoms within a short period of time.
Pepsin, as mentioned earlier, is a protease produced in the stomach that is activated by the acid in the stomach. Pepsin is active in a very narrow pH range, pH 1 3. This enzyme loses activity very rapidly above pH 3 and is inactive at a pH of more than 3.5. Antacids and H2 blockers relieve symptoms of heartburn by raising the pH of the stomach. Experiments have shown that the pH of the stomach is raised to between 5 and 6 when antacids are administered. At that high pH level pepsin is rendered inactive consequently halting protein digestion in the stomach. It has escaped mainstream attention that the near-epidemic use of antacids in the U.S. brings some consequence. Apart from the disturbance of normal human gut microbial flora, raising the pH of the gastric environment renders the endogenous proteolytic enzyme pepsin inactive. This unintended effect, in turn, may exacerbate one of the potential underlying conditions of indigestion: pancreatic insufficiency.
For these and other reasons, therefore, it would be a difficult but much desired advance in the art to provide effective methods, kits, combinations, and/or compositions for supplementing the activity of internally produced digestive enzymes. Supplemental digestive enzymes can alleviate the problem of poor digestion due to poor internal production of digestive enzymes, and enable enhanced absorption of nutrients from ingested food from the digestive tract.
Fungal proteases have a broad pH range and work in acidic as well as neutral environments. As shown below, a combination of fungal and bacterial proteases and fungal lipases, with either antacids or H2 blockers are not only effective in relieving heartburn but also ensure that protein and fat digestion continues in the stomach.
As hereinafter described, the present invention is an improvement over the disclosures of U.S. Pat. Nos. 6,013,680 and 5,629,013.